In-patient Comparison of Immediately Loaded and Non-loaded Submerged and Transgingival Healed Implants Within 4 Months A Controlled Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
The study involves 20 patients who require implant treatment for the edentulous lower jaw, following specific inclusion and exclusion criteria. Patients are drawn from the regular pool of those seeking implant therapy, with no additional recruitment efforts.
This study compares the effects of loaded and non-loaded dental implants. Preoperative assessments include medical histories, clinical, and radiographic examinations of the jaw. Participants are thoroughly informed about the study procedures and consent to participate through signed agreements. They undergo preoperative diagnostics, including panoramic X-rays to evaluate mandibular bone height, and complete the OHIP-G 14 questionnaire to establish a baseline for their oral health-related quality of life.
The implant placement involves standard outpatient surgical procedures under local anesthesia. The implants used are CE-certified and are placed in predetermined positions in the edentulous region. During the surgery intraoral scans and conventional impressions are performed. Post-operative care includes oral rinses, and radiographic assessments, with follow-up visits scheduled for suture removal and further assessments using the visual analog scale for pain and swelling.
The healing phase spans four months, during which patients' comfort and oral health are monitored through clinical examinations and additional questionnaires. Follow-up after 4 months includes re-entry surgery and further radiographic evaluations and intraoral scans to assess the bone's response around the implants. Throughout the study, adverse events and patient satisfaction are continuously documented.
In the later stages, regular follow-up visits for up to 24 months post-surgery to monitor implant stability and health through clinical and radiographic check-ups are performed.
This study aims to document implant survival rates, peri-implant bone regeneration, assess biological and technical complications, and evaluate patient satisfaction and quality of life throughout the implant process, providing valuable data for future dental implant protocols.
详细描述
The clinical study conducted at the Dental School of the Medical University of Graz is designed to evaluate the effects and outcomes of loaded versus non-loaded dental implants in patients requiring treatment for an edentulous lower jaw. This study includes 20 patients who meet specific inclusion and exclusion criteria and are recruited from the regular pool of patients at the facility, without any special recruitment efforts.
Study Overview The primary objective of this study is to compare the integration and performance of loaded and non-loaded dental implants. Before the study procedures begin, each participant undergoes a thorough preoperative evaluation, which includes a complete medical history review and a detailed clinical and radiographic examination of the recipient site in the jaw. These initial assessments are crucial for ensuring patient safety and suitability for the study.
Informed Consent and Patient Information All participants receive detailed patient information leaflets that explain the study's purpose, procedures, potential risks, and benefits. This is followed by obtaining informed consent through a separate agreement form, ensuring that all participants are fully aware and agreeable to the study's terms.
Preoperative Procedures The preoperative phase includes radiological diagnostics, such as panoramic x-rays to evaluate the mandibular bone and measure residual bone height. Additionally, participants complete the OHIP-G 14 questionnaire to gauge their oral health-related quality of life at baseline. Intraoral photographs are also taken to document each patient's initial condition.
Surgical Procedure and Implant Placement The surgical procedures are performed under local anesthesia in a septic environment typical of outpatient settings. Each patient rinses with a 0.2% chlorhexidine digluconate solution preoperatively. A full-thickness flap is prepared, and the bone is assessed for quality and quantity before implant placement. The implants, all CE-certified and of the same design, are placed in six predetermined positions in the interforaminal region of the lower jaw.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The positioning and loading protocols of the implants under investigation are blinded to the investigator during the analysis of peri-implant bone heights, which are measured using periodontal probes, as well as during the analysis of intraoperative scans and impressions.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written consent of the participant after being informed Capability of giving an informed consent
- •good health as defined by the subjects medical history (no contraindications as described in the
排除标准
- •age 20 to 80 years
- •Patients who require 6 implants in the positions 32, 33, 34, 42, 43, 44
- •edentulous mandible with enough interforaminal bone volume for placement of 6 implants
- •Residual vertical bone height of at least 8mm in the interforaminal region
- •Patients who wish implant-supported restoration with six implants
- •Exclusion Criteria:
- •Homelessness
- •Medication with a contraindication for implant therapy
- •Skeletal immaturity
- •Any active malignancy or ongoing treatment for malignancy
- •An active infection at the operative site
- •Persistent compartment syndrome or neurovascular residua of compartment syndrome
- •Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone
- •Contraindications to the class of devices under study, e.g. known hypersensitivity or allergy to class of devices
- •Pregnancy
- •Intention to become pregnant during the course of the study
- •Breast feeding
- •Lack of safe contraception
结局指标
主要结局
Survival
时间窗: 24 months
Implant survival
次要结局
- Visual Analogue Scale for Pain assessment(0 to 24 months)
- Oral Health Impact Profile-14 in German(0 to 24 months)
- Bleeding on Probing(0 to 24 months)
- Peri-implant bone height(0 and 4 months)
- Probing Around Implants(0 to 24 months)
- Plaque Index(0 to 24 months)